Sr. QA Specialist, Raw Material Quality

Alnylam Pharmaceuticals • Cambridge, MA

20h • Hybrid

About The Position

Reporting to the Associate Director of Raw Material Quality, this individual will be responsible for ensuring GMP compliance of raw material management activities internally and externally for Alnylam’s pipeline.
Provide QA life cycle oversight over the Alnylam raw material management and related quality systems from drug discovery through to clinical and commercial operations.
Own and lead Supplier Investigation Requests and Supplier Change Notifications.
Provide support with vendor and material qualification activities for domestic and international suppliers of raw materials.
Serve as QA contact for key raw material suppliers to support event documents (deviation, change control, etc.) and technical reports review.
Provide technical expertise around raw material management and warehousing including quality and compliance standards, testing, qualification, and release.
Support internal/external audits and regulatory inspections, as well as supplier audits as needed.
Assist in maintenance and evolution of Alnylam’s raw material management quality systems and processes.
Contribute to regulatory submissions, as appropriate.
Maintain quality metrics and present the metrics data to different audience.
Travel possible, up to 15%.

Requirements

• B.S. in applicable science or engineering field.
• 5+ years of experience in Quality Control and/or Quality Assurance is required.
• Established background in raw materials management.
• Hands-on experience processing quality records (deviation, change control, CAPA, etc.).
• Experience with overseeing and coordinating work with external suppliers/vendors.
• Working knowledge with CFR, ICH, Eudralex and USP/EP/JP.
• Excellent team skills, organization, and strong interpersonal communication skills (written and verbal).
• Ability to adapt to a rapidly changing environment.
• Proficient knowledge of common software (e.g., EXCEL, PowerPoint, Word, etc.).

Responsibilities

• Provide QA life cycle oversight over the Alnylam raw material management and related quality systems from drug discovery through to clinical and commercial operations.
• Own and lead Supplier Investigation Requests and Supplier Change Notifications.
• Provide support with vendor and material qualification activities for domestic and international suppliers of raw materials.
• Serve as QA contact for key raw material suppliers to support event documents (deviation, change control, etc.) and technical reports review.
• Provide technical expertise around raw material management and warehousing including quality and compliance standards, testing, qualification, and release.
• Support internal/external audits and regulatory inspections, as well as supplier audits as needed.
• Assist in maintenance and evolution of Alnylam’s raw material management quality systems and processes.
• Contribute to regulatory submissions, as appropriate.
• Maintain quality metrics and present the metrics data to different audience.

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• generous family resources and leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level